Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK007AA | IM / LL |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | — | RL |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK007AA | OT / LL |
pentacel being administered to the patient past the expiration date with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 4 months old male patient who received an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/Ipv(Vero)/Hib(Prp/T) vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine (Pneumococcal 20) for Immunisation. On 01-Apr-2025, the patient received 0.5ml (Dose 1) (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/Ipv(Vero)/Hib(Prp/T) vaccine, Strength Standard, Expiry date 28-Mar-2025 and lot UK007AA via intramuscular route in the left vastus lateralis for immunization, past its expiration date with no reported adverse event (expired product administered) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
PNEUMOCOCCAL VACCINE